RU2011130526A - Композиции для введения лекарственных средств - Google Patents
Композиции для введения лекарственных средств Download PDFInfo
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- 239000000203 mixture Substances 0.000 title claims abstract 31
- 239000003814 drug Substances 0.000 title 1
- -1 flovatriptan Chemical compound 0.000 claims abstract 19
- ZISSAWUMDACLOM-UHFFFAOYSA-N triptane Chemical class CC(C)C(C)(C)C ZISSAWUMDACLOM-UHFFFAOYSA-N 0.000 claims abstract 13
- KQKPFRSPSRPDEB-UHFFFAOYSA-N sumatriptan Chemical compound CNS(=O)(=O)CC1=CC=C2NC=C(CCN(C)C)C2=C1 KQKPFRSPSRPDEB-UHFFFAOYSA-N 0.000 claims abstract 12
- 229960003708 sumatriptan Drugs 0.000 claims abstract 10
- 239000008280 blood Substances 0.000 claims abstract 9
- 210000004369 blood Anatomy 0.000 claims abstract 9
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 claims abstract 6
- 150000003839 salts Chemical class 0.000 claims abstract 5
- UYEMNFYVTFDKRG-UHFFFAOYSA-N 2-[4,5-dihydroxy-2-(hydroxymethyl)-6-undecoxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-3,4,5-triol Chemical group OC1C(O)C(OCCCCCCCCCCC)OC(CO)C1OC1C(O)C(O)C(O)C(CO)O1 UYEMNFYVTFDKRG-UHFFFAOYSA-N 0.000 claims abstract 3
- WKEMJKQOLOHJLZ-UHFFFAOYSA-N Almogran Chemical compound C1=C2C(CCN(C)C)=CNC2=CC=C1CS(=O)(=O)N1CCCC1 WKEMJKQOLOHJLZ-UHFFFAOYSA-N 0.000 claims abstract 3
- AYOPSBMGRBUJSJ-VQXBOQCVSA-N [(2s,3s,4s,5r)-3,4-dihydroxy-5-(hydroxymethyl)-2-[(2r,3r,4s,5s,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxolan-2-yl]methyl dodecanoate Chemical compound O([C@@H]1[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O1)O)[C@]1(COC(=O)CCCCCCCCCCC)O[C@H](CO)[C@@H](O)[C@@H]1O AYOPSBMGRBUJSJ-VQXBOQCVSA-N 0.000 claims abstract 3
- 229960002133 almotriptan Drugs 0.000 claims abstract 3
- NLEBIOOXCVAHBD-QKMCSOCLSA-N dodecyl beta-D-maltoside Chemical compound O[C@@H]1[C@@H](O)[C@H](OCCCCCCCCCCCC)O[C@H](CO)[C@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 NLEBIOOXCVAHBD-QKMCSOCLSA-N 0.000 claims abstract 3
- 229960002472 eletriptan Drugs 0.000 claims abstract 3
- OTLDLQZJRFYOJR-LJQANCHMSA-N eletriptan Chemical compound CN1CCC[C@@H]1CC1=CN=C2[C]1C=C(CCS(=O)(=O)C=1C=CC=CC=1)C=C2 OTLDLQZJRFYOJR-LJQANCHMSA-N 0.000 claims abstract 3
- 229960005254 naratriptan Drugs 0.000 claims abstract 3
- UNHGSHHVDNGCFN-UHFFFAOYSA-N naratriptan Chemical compound C=12[CH]C(CCS(=O)(=O)NC)=CC=C2N=CC=1C1CCN(C)CC1 UNHGSHHVDNGCFN-UHFFFAOYSA-N 0.000 claims abstract 3
- 229960001360 zolmitriptan Drugs 0.000 claims abstract 3
- UTAZCRNOSWWEFR-ZDUSSCGKSA-N zolmitriptan Chemical compound C=1[C]2C(CCN(C)C)=CN=C2C=CC=1C[C@H]1COC(=O)N1 UTAZCRNOSWWEFR-ZDUSSCGKSA-N 0.000 claims abstract 3
- 125000000217 alkyl group Chemical group 0.000 claims abstract 2
- 125000004432 carbon atom Chemical group C* 0.000 claims abstract 2
- 229930182470 glycoside Natural products 0.000 claims abstract 2
- 239000000693 micelle Substances 0.000 claims abstract 2
- QIVBCDIJIAJPQS-VIFPVBQESA-N L-tryptophane Chemical class C1=CC=C2C(C[C@H](N)C(O)=O)=CNC2=C1 QIVBCDIJIAJPQS-VIFPVBQESA-N 0.000 claims 2
- 208000019695 Migraine disease Diseases 0.000 claims 2
- 208000002193 Pain Diseases 0.000 claims 2
- 229940090436 imitrex Drugs 0.000 claims 2
- 206010027599 migraine Diseases 0.000 claims 2
- 101100228469 Caenorhabditis elegans exp-1 gene Proteins 0.000 claims 1
- 238000002347 injection Methods 0.000 claims 1
- 239000007924 injection Substances 0.000 claims 1
- 239000007922 nasal spray Substances 0.000 claims 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7012—Compounds having a free or esterified carboxyl group attached, directly or through a carbon chain, to a carbon atom of the saccharide radical, e.g. glucuronic acid, neuraminic acid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/26—Glucagons
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0043—Nose
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0048—Eye, e.g. artificial tears
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61P25/04—Centrally acting analgesics, e.g. opioids
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- A61P25/00—Drugs for disorders of the nervous system
- A61P25/06—Antimigraine agents
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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Abstract
1. Композиция, включающаяa) терапевтически эффективное количество аналога триптана, выбираемого из суматриптана, наратриптана, элетриптана, фловатриптана, алмотриптана, золмитриптана, их соли или их комбинации, иb) алкилсахарид.2. Композиция по п.1, в которой концентрация алкилсахарида составляет приблизительно 0,05-2% или приблизительно 0,1-0,25%.3. Композиция по п.1, в которой алкилсахарид имеет алкильную цепь, включающую 10-16 атомов углерода.4. Композиция по п.3, в которой алкилсахаридом является ундецил-β-D-мальтозид, додецил-β-D-мальтозид, тридецил-β-D-мальтозид, тетрадецил-β-D-мальтозид, сахарозы монододеканоат или их комбинация.5. Композиция по п.1, составленная для интраназальной доставки.6. Композиция по п.1, в которой алкилгликозид имеет критическую концентрацию мицеллообразования (СМС), составляющую менее чем приблизительно 1 мМ или менее чем приблизительно 0,5 мМ.7. Композиция по п.1, которая дополнительно включает этилендиаминтетрауксусную кислоту (EDTA) или ее соль, и в которой концентрация EDTA составляет приблизительно 0,01%-2% в весовом отношении.8. Композиция по п.1, имеющая рН, составляющий приблизительно 7,0 или меньше.9. Композиция по п.1, которая обеспечивает Cmax аналога триптана, превышающую в приблизительно 1,3 раза или больше соответствующую Cmax, обеспечиваемую в отсутствие алкилсахарида.10. Композиция по п.1, которая обеспечивает максимальную концентрацию в плазме или крови аналога триптана в момент времени, представляющий собой менее чем приблизительно 20 мин после введения человеку, которая превышает в, по крайней мере, приблизительно 1,3 раза, 1,5 раз или больше концентрацию в плазме или крови аналога триптана в момент вре�
Claims (20)
1. Композиция, включающая
a) терапевтически эффективное количество аналога триптана, выбираемого из суматриптана, наратриптана, элетриптана, фловатриптана, алмотриптана, золмитриптана, их соли или их комбинации, и
b) алкилсахарид.
2. Композиция по п.1, в которой концентрация алкилсахарида составляет приблизительно 0,05-2% или приблизительно 0,1-0,25%.
3. Композиция по п.1, в которой алкилсахарид имеет алкильную цепь, включающую 10-16 атомов углерода.
4. Композиция по п.3, в которой алкилсахаридом является ундецил-β-D-мальтозид, додецил-β-D-мальтозид, тридецил-β-D-мальтозид, тетрадецил-β-D-мальтозид, сахарозы монододеканоат или их комбинация.
5. Композиция по п.1, составленная для интраназальной доставки.
6. Композиция по п.1, в которой алкилгликозид имеет критическую концентрацию мицеллообразования (СМС), составляющую менее чем приблизительно 1 мМ или менее чем приблизительно 0,5 мМ.
7. Композиция по п.1, которая дополнительно включает этилендиаминтетрауксусную кислоту (EDTA) или ее соль, и в которой концентрация EDTA составляет приблизительно 0,01%-2% в весовом отношении.
8. Композиция по п.1, имеющая рН, составляющий приблизительно 7,0 или меньше.
9. Композиция по п.1, которая обеспечивает Cmax аналога триптана, превышающую в приблизительно 1,3 раза или больше соответствующую Cmax, обеспечиваемую в отсутствие алкилсахарида.
10. Композиция по п.1, которая обеспечивает максимальную концентрацию в плазме или крови аналога триптана в момент времени, представляющий собой менее чем приблизительно 20 мин после введения человеку, которая превышает в, по крайней мере, приблизительно 1,3 раза, 1,5 раз или больше концентрацию в плазме или крови аналога триптана в момент времени, представляющий собой приблизительно 60 мин после введения.
11. Композиция по п.1, которая обеспечивает Cmax аналога триптана в плазме или крови в пределах менее приблизительно 20 мин после введения человеку, причем концентрация алкилсахарида составляет 0,05-0,2%, и концентрацию аналога триптана через 60 мин, сохраняемую на уровне, составляющем, по крайней мере, приблизительно 0,25х=Cmax.
12. Композиция по п.1, в которой аналогом триптана является суматриптан, и которая составлена для интраназального введения.
13. Композиция по п.12, которая имеет биодоступность относительно IMITREX® для инъекции, составляющую, по крайней мере, приблизительно 17%, и AUC0-1 ч, составляющую приблизительно 10 нг.ч/мл или больше, или которая имеет биодоступность относительно назального аэрозоля IMITREX®, составляющую по крайней мере приблизительно 120%, и AUC0-1 ч, составляющую приблизительно 10 нг.ч/мл или больше.
14. Композиция по п.12, которая имеет Cmax, превышающую 15 нг/мл, или имеет отношение доза/Cmax, превышающее приблизительно 1×10(exp 6) мл (exp-1) (1×106 мл-1).
15. Композиция по п.12, которая имеет Tmax, составляющее менее приблизительно 20 мин, или Tmax, составляющее менее приблизительно 15 мин.
16. Композиция по п.12, в которой концентрация суматриптана находится между 5 мг и 100 мг.
17. Композиция по п.12, которая обеспечивает AUC0-1 ч, превышающую приблизительно 10 нг.ч/мл.
18. Композиция по п.12, которая обеспечивает уровень суматриптана в плазме или крови, превышающий или равный приблизительно 5 нг/мл через приблизительно 2 мин или меньше, или которая обеспечивает уровень суматриптана в плазме или крови, превышающий или равный приблизительно 5 нг/мл через приблизительно 5 мин или меньше, или которая обеспечивает уровень суматриптана в плазме или крови, превышающий или равный приблизительно 10 нг/мл через приблизительно 15 мин или меньше.
19. Композиция по п.12, которая включает приблизительно 20 мг суматриптана и обеспечивает уровень суматриптана в плазме или крови, превышающий или равный приблизительно 16 нг/мл через приблизительно 20 мин или меньше.
20. Композиция, включающая
a) терапевтически эффективное количество аналога триптана, выбираемого из суматриптана, наратриптана, элетриптана, фловатриптана, алмотриптана, золмитриптана, их соли или их комбинации, и
b) алкилсахарид, выбираемый из ундецил-β-D-мальтозида, додецил-β-D-мальтозида, тридецил-β-D-мальтозида, тетрадецил-β-D-мальтозида, сахарозы монододеканоата или их комбинации,
которая предоставляет нуждающемуся в этом субъекту уменьшенное, но терапевтически эффективное количества аналога триптана, и при этом площадь под кривой (AUC) приблизительно равна AUC, обеспечиваемой увеличенным терапевтически эффективным количеством аналога триптана, вводимым в отсутствие алкилсахарида; или
которая обеспечивает для аналога триптана AUC0-1 ч, превышающую в приблизительно 1,3 раза, 1,5 раз или больше соответствующую AUC0-1 ч, обеспечиваемую в отсутствие алкилсахарида;
которая демонстрирует Tmax, составляющее приблизительно 30 мин или меньше, у субъекта, посредством чего обеспечивается быстрое возникновение курирования боли при мигрени, или
которая обеспечивает Tmax, составляющее менее приблизительно 20 мин, посредством чего обеспечивается уменьшенная частота повторения боли при мигрени у субъекта.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US12/341,696 US8268791B2 (en) | 2004-08-25 | 2008-12-22 | Alkylglycoside compositions for drug administration |
| US12/341,696 | 2008-12-22 | ||
| PCT/US2009/069326 WO2010075465A1 (en) | 2008-12-22 | 2009-12-22 | Compositions for drug administration |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2011130526A true RU2011130526A (ru) | 2013-01-27 |
| RU2554814C2 RU2554814C2 (ru) | 2015-06-27 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2011130526/15A RU2554814C2 (ru) | 2008-12-22 | 2009-12-22 | Композиции для введения лекарственных средств |
Country Status (14)
| Country | Link |
|---|---|
| US (1) | US8268791B2 (ru) |
| EP (1) | EP2381773B1 (ru) |
| JP (2) | JP5752048B2 (ru) |
| KR (1) | KR101719008B1 (ru) |
| CN (1) | CN102325450B (ru) |
| AU (1) | AU2009329952B2 (ru) |
| BR (1) | BRPI0923403B1 (ru) |
| CA (1) | CA2748268C (ru) |
| DK (1) | DK2381773T3 (ru) |
| ES (1) | ES2667248T3 (ru) |
| MX (1) | MX356271B (ru) |
| NZ (1) | NZ593782A (ru) |
| RU (1) | RU2554814C2 (ru) |
| WO (1) | WO2010075465A1 (ru) |
Families Citing this family (55)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7731947B2 (en) | 2003-11-17 | 2010-06-08 | Intarcia Therapeutics, Inc. | Composition and dosage form comprising an interferon particle formulation and suspending vehicle |
| US9895444B2 (en) | 2004-08-25 | 2018-02-20 | Aegis Therapeutics, Llc | Compositions for drug administration |
| US11246913B2 (en) | 2005-02-03 | 2022-02-15 | Intarcia Therapeutics, Inc. | Suspension formulation comprising an insulinotropic peptide |
| WO2006083761A2 (en) | 2005-02-03 | 2006-08-10 | Alza Corporation | Solvent/polymer solutions as suspension vehicles |
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| CA2748268A1 (en) | 2010-07-01 |
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| MX356271B (es) | 2018-05-21 |
| HK1164059A1 (en) | 2012-09-21 |
| CN102325450A (zh) | 2012-01-18 |
| EP2381773B1 (en) | 2018-02-14 |
| KR20110099049A (ko) | 2011-09-05 |
| KR101719008B1 (ko) | 2017-03-22 |
| BRPI0923403A2 (pt) | 2020-08-11 |
| WO2010075465A1 (en) | 2010-07-01 |
| CN102325450B (zh) | 2015-06-17 |
| CA2748268C (en) | 2018-05-15 |
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